Department: Post Approval Monitoring and Education
SOP # 1-4
Revision #3:
TITLE: Review of Study Signed
Approved By:
Associate VP for
Research
Approved By:
Research
Compliance
Monitor
Approved By
Research
Compliance
Monitor
David J. Hudson
Date
7/14/15
Jane Lehmbeck
Date
7/14/15
Elaine Dube
Date
7/14/15
Page: 1 of 1
Consent Forms
Date First Effective:
6/15/06
Revision Date:
11/1/06
3/1/09
6/30/15
OBJECTIVE
To define the procedures utilized to review the informed consent documents maintained in the
investigator’s research records. This procedure is to verify that documentation of informed consent is
performed according to Federal Policy (45 part 46) and, where applicable FDA (21 CFR 50). The
informed consent process must also meet the policies of the University of Virginia’s IRB-HSR and,
where applicable, the School of Medicine Clinical Research Standard Operating Procedures.
RESPONSIBILITY
Research Compliance Monitors are responsible for verifying the appropriate documentation of informed
consent for research studies selected for Post Approval Monitoring review.
PROCEDURES
1. Review subject signed informed consent forms for the presence of the following documentation:

date the informed consent document was signed;

utilization of the correct version of the IRB approved consent forms denoted by the presence
of the IRB approval stamp date (if applicable);

the signature and date of the subject or the signature of the subject’s legal representative;

the signature and date of the person obtaining consent.
2. Additional items that may be assessed during the review of the informed consent documents
include but are not limited to:
 consistency between the type and frequency of side effects listed in the informed consent
document to those that actually occurred;
 approved consent is consistent with approved protocol;
 presence of any extemporaneous modifications to the consent documentation;
 subject signed prior to study-specific procedures being initiated;
 non-English speaking subjects signed an approved version of consent form if applicable (i.e.
English and Spanish short forms)
REFERENCES:
Form Informed Consent Checklist 1-4A